FDA approves Moderna’s Next-Generation COVID-19 vaccine, mNEXSPIKE

USA—Moderna has received approval from the U.S. Food and Drug Administration (FDA) for its next-generation COVID-19 vaccine, known as mNEXSPIKE (mRNA-1283), representing a significant advancement in the battle against the virus.

The FDA authorized the vaccine for use in adults aged 65 and older, as well as in individuals aged 12 to 64 who have at least one underlying health condition that increases their risk of severe COVID-19, such as asthma, diabetes, or chronic obstructive pulmonary disease (COPD).

This approval comes amid evolving FDA policies that have introduced more stringent requirements for COVID-19 vaccines.

Moderna’s CEO, Stéphane Bancel, emphasized that mNEXSPIKE adds an important new tool to protect those at high risk of severe disease, highlighting that COVID-19 remains a serious public health threat, with over 47,000 deaths in the U.S. last year alone.

The FDA’s decision was based on results from a large Phase 3 clinical trial involving approximately 11,400 participants aged 12 and older.

The study compared mNEXSPIKE, administered at a 10 microgram dose, to Moderna’s original vaccine, Spikevax (mRNA-1273), given at a 50 microgram dose.

The trial demonstrated that mNEXSPIKE was not only as effective as Spikevax but showed a 9.3% higher relative vaccine efficacy in participants aged 12 and older.

 In adults 65 and older, a subgroup analysis revealed an even greater improvement, with a 13.5% higher efficacy.

One notable advantage of mNEXSPIKE is its lower dose—one-fifth that of Spikevax—which may contribute to fewer side effects and easier manufacturing.

Additionally, the vaccine is reportedly refrigerator-stable, which simplifies storage and distribution, especially in regions where maintaining ultra-cold temperatures is challenging.

The vaccine targets the Omicron JN.1 variant of SARS-CoV-2 and works by teaching the immune system to recognize key parts of the virus’s spike protein, thereby enhancing protection.

Common side effects are similar to those seen with previous COVID-19 vaccines and include injection site pain, swelling, fatigue, headache, muscle and joint pain, chills, nausea, and fever.

Moderna plans to make mNEXSPIKE available for the 2025-2026 respiratory virus season in the United States, alongside its existing Spikevax vaccine, which remains authorized for use in individuals aged 6 months and older without restrictions.

This approval follows a period of uncertainty at the FDA regarding COVID-19 vaccine approvals.

Earlier in the year, the agency missed its decision deadline for Novavax’s protein-based vaccine without explanation, and FDA Commissioner Marty Makary publicly indicated that the agency was reassessing its approach to COVID-19 vaccine approvals.

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